FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
20785–20808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2020
SmoothSkin Pure
K200184 · OHT
Cyden Limited
General & Plastic Surgery · 28d
Cleared Feb 20, 2020
SDS2.2 dental implant
K190406 · DZE
Sds Swiss Dental Solutions AG
Dental · 364d
Cleared Feb 20, 2020
Flowart
K190806 · FPA
Asset Medikal Tasarim As.
General Hospital · 328d
Cleared Feb 20, 2020
X-MIND Trium
K191719 · MUH
De Gotzen S.R.L.
Radiology · 239d
Cleared Feb 20, 2020
Potenza
K192545 · GEI
Jeisys Medical Incorporated
General & Plastic Surgery · 157d
Cleared Feb 20, 2020
Gemini 810+980 Soft Tissue Laser
K192617 · GEX
Azena Medical, LLC
General & Plastic Surgery · 150d
Cleared Feb 20, 2020
ApneaTrak
K192624 · OLV
Cadwell Industries, Inc.
Neurology · 150d
Cleared Feb 20, 2020
Video Laparoscope, Video Processor, Light Source
K192918 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 128d
Cleared Feb 20, 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K192922 · NQQ
Gentuity, LLC
Cardiovascular · 127d
Cleared Feb 20, 2020
HydroPICC (PICC-142)
K193015 · LJS
Access Vascular, Inc.
General Hospital · 114d
Cleared Feb 20, 2020
Exactech® Equinoxe® Reverse Shoulder Glenospheres
K193098 · PHX
Exactech, Inc.
Orthopedic · 105d
Cleared Feb 20, 2020
Largo PEEK Interbody System
K193255 · MAX
Flospine, LLC
Orthopedic · 86d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303 · KLW
GN Hearing A/S
Ear, Nose, Throat · 83d
Cleared Feb 20, 2020
WIN Flexible Nail System
K193533 · JDS
Biomet, Inc.
Orthopedic · 62d
Cleared CT Feb 20, 2020
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K193596 · DQY
Reflow Medical
Cardiovascular · 59d
Cleared Feb 19, 2020
D R Burton OxyPAP
K192000 · BWF
D R Burton Healthcare, LLC
Anesthesiology · 208d
Cleared Feb 19, 2020
Sentinel Cerebral Protection System
K192460 · PUM
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Feb 19, 2020
densitas densityai
K192973 · LLZ
Densitas, Inc.
Radiology · 118d
Cleared Feb 19, 2020
speX Support Catheter
K193012 · DQY
Reflow Medical
Cardiovascular · 113d
Cleared Feb 19, 2020
Wego-Stainless Steel
K193209 · GAQ
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 19, 2020
ClearCam System
K200228 · GCJ
Clearcam, LLC
General & Plastic Surgery · 20d
Cleared Feb 18, 2020
InPen Dose Calculator
K190487 · NDC
Companion Medical, Inc.
Chemistry · 355d
Cleared Feb 18, 2020
CareStart Flu A&B Plus
K191514 · PSZ
Access Bio, Inc.
Microbiology · 256d
Cleared Feb 18, 2020
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing...
K192381 · LBH
Scientific Pharmaceuticals
Dental · 172d